跳至主要内容
临床试验/NCT07679009
NCT07679009Enrolling By Invitation不适用

Evaluating the Safety and Diagnostic Utility of Cardiac MRI in Patients With Abandoned, Fractured Endocardial Leads or Permanent Epicardial Leads

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Evaluating the safety of CMR

研究概览

简要总结

This is a prospective cohort study looking to systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present).

详细描述

This is a prospective cohort study involving patients with abandoned, fractured endocardial leads, or surgically placed permanent epicardial leads with or without concurrent active cardiac implantable electronic devices (CIEDs), who need cardiac MRI for clinical indications. Participants will undergo a thorough pre-scan evaluation, including chest x-ray (CXR), device interrogation, lead integrity check, and risk assessment. The MRI will be performed using a standardized protocol designed to minimize risks, with continuous patient monitoring during the procedure. Post-scan device interrogation and patient evaluation will assess any immediate and delayed adverse effects.

This study is a descriptive case series, and no statistical comparisons with controls will be made. Descriptive statistics of continuous patient and CIED variables are expressed as the mean+/- SDs (standard deviations), or as medians with interquartile ranges (IOR). Categorical variables are expressed as numbers and percentages.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals 18 years and older
  • Individuals with abandoned, fractured endocardial
  • Individuals with permanent epicardial pacemaker or implantable cardioverter-defibrillator (ICD) leads

排除标准

  • Within 6 weeks post device implantation, unless more urgent clinical needs dictate an earlier scan;
  • Pregnant individuals
  • Individuals with severe claustrophobia
  • Individuals with other known contraindications for MRI, as determined by study doctor

结局指标

主要结局

Evaluating the safety of CMR

时间窗: 6 months

To systematically evaluate the safety of conducting cardiac Magnetic Resonance Imaging (MRI) in this high-risk patient group with abandoned, fractured endocardial leads or surgically implanted permanent epicardial leads, by monitoring clinical outcome and device functionality (if active device present). This is done by evaluating and reviewing the CMR images.

次要结局

  • Diagnostic Value of CMR(6 months)
  • Protocol Development.(2 years.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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